Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

Официальное название

Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.

Обзор

This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.

Подробное описание

This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion

Вмешательства

• Процедура Punctal plug occlusion
  Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

Первичные конечные точки

• 1. Effectiveness [Срок оценки: Baseline, 2 weeks, 4 weeks, 3 months and 6 months]

Вторичные конечные точки (12)

• Change in lower tear meniscus heigh [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change in lower tear meniscus area [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI) [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale. [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change in tear film break-up time (TFBUT). [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change in non-invasive tear break-up time (NIBUT). [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS). [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change in Schirmer I test results. [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Change in corneal sensitivity. [Срок оценки: Baseline to 3 months after upper punctal plug placement.]
• Incidence of epiphora after upper punctal plug placement. [Срок оценки: Up to 3 months after upper punctal plug placement.]
• Upper punctal plug retention rate. [Срок оценки: Up to 3 months after upper punctal plug placement.]

Критерии участия

Критерии включения

• Patients of both sexes
• One or both eyes may be included
• Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination
• Functional superior lacrimal punctum
• Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)
• Age >18 years
• OSDI score >13 and one of the following signs: Tear film markers (Fluorescein tear break up-time <5, First non-invasive tear breakup time <10, Schirmer test without anesthesia <10 mm, Schirmer test with anesthesia <10 mm), Ocular surface markers (corneal staining >5 spots or conjunctival staining >9 spots).

Критерии исключения

• Active ocular surface infection.
• Patients who are unwilling to participate or to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Мексика · 1 центр

• Ophthalmology Department — Monterrey

Публикации

• Qiu W, Liu Z, Ao M, Li X, Wang W. Punctal plugs versus artificial tears for treating primary Sjogren's syndrome with keratoconjunctivitis SICCA: a comparative observation of their effects on visual function. Rheumatol Int. 2013 Oct;33(10):2543-8. doi: 10.1007/s00296-013-2769-1. Epub 2013 May 7. PMID 23649850
• Perez VL, Chen W, Craig JP, Dogru M, Jones L, Stapleton F, Wolffsohn JS, Sullivan DA. TFOS DEWS III: Executive Summary. Am J Ophthalmol. 2026 Feb;282:135-145. doi: 10.1016/j.ajo.2025.09.035. Epub 2025 Sep 24. PMID 41005521
• Marcet MM, Shtein RM, Bradley EA, Deng SX, Meyer DR, Bilyk JR, Yen MT, Lee WB, Mawn LA. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Aug;122(8):1681-7. doi: 10.1016/j.ophtha.2015.04.034. Epub 2015 May 30. PMID 26038339
• Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf. 2016 Apr;14(2):189-95. doi: 10.1016/j.jtos.2015.10.004. Epub 2016 Feb 2. PMID 26850527
• Kaido M, Ishida R, Dogru M, Tsubota K. Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. Am J Ophthalmol. 2013 Apr;155(4):648-653, 653.e1. doi: 10.1016/j.ajo.2012.10.024. Epub 2013 Jan 11. PMID 23317650
• Hallali G, Guindolet D, Gabison EE, Cochereau I, Doan S. Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. Cornea. 2024 Jul 1;43(7):890-894. doi: 10.1097/ICO.0000000000003477. Epub 2024 Jan 30. PMID 38289716
• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. PMID 28736335
• Chen F, Wang J, Chen W, Shen M, Xu S, Lu F. Upper punctal occlusion versus lower punctal occlusion in dry eye. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5571-7. doi: 10.1167/iovs.09-5097. Epub 2010 May 12. PMID 20463310

Идентификаторы

NCT: NCT07571330 · OF25-00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗